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NCT03914612 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer
A Phase 3 study of Recurrent Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 813
- Enrollment target
- 20
- Study locations
NCT03914612: Active Phase 3 study of Recurrent Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT03914612 is a Phase 3 study of Recurrent Endometrial Carcinoma and Endometrial Serous Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 813 participants, above the 210-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (287% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03914612, a Phase 3 study of Recurrent Endometrial Carcinoma and Endometrial Serous Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 813 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Paclitaxel and carboplatin are chemotherapy drugs used as part of the usual treatment approach for this type of cancer. This study aims to assess if adding immunotherapy to these drugs is better or worse than the usual approach for treatment of this cancer.
Primary Outcome
Progression free survival (PFS) Note: For arm 2 (dMMR Cohort), the point estimate and the upper limit of the confidence interval are not able to be estimated due to insufficient events.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- PROCEDURE Computed Tomography
- DRUG Paclitaxel
- OTHER Placebo Administration
Study Locations (20)
California
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Community Cancer Institute - Clovis
- City of Hope Comprehensive Cancer Center - Duarte
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- City of Hope Antelope Valley - Lancaster
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Palo Alto Medical Foundation-Gynecologic Oncology - Mountain View
Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Alaska
- Alaska Women's Cancer Care - Anchorage
Arizona
- CTCA at Western Regional Medical Center - Goodyear
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 813 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2026-09-26 |
| Phase | Phase 3 |
What the registry record for NCT03914612 still lists
NCT03914612 is an interventional study that assigns participants to a tested intervention. The registered 813 participants enrollment target is mid-sized for trials with a published cap, above the 210-participant average among 19 other Recurrent Endometrial Carcinoma trials with a reported enrollment target (287% higher).
The record links to 10 conditions, with Recurrent Endometrial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03914612 names 20 study sites across 5 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT03914612 about?
NCT03914612 is a clinical study titled "Testing the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer". This phase III trial studies how well the combination of pembrolizumab, paclitaxel and carboplatin works compared with paclitaxel and carboplatin alone in treating patients with endometrial cancer that is stage III or IV, or has come back after a period of improvement (recurrent). Immunotherapy with...
What is the current status of trial NCT03914612?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2019-08-22. Estimated completion is 2026-09-26.
What conditions does trial NCT03914612 study?
This clinical trial studies the following conditions: Recurrent Endometrial Carcinoma, Endometrial Serous Adenocarcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Endometrioid Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma.
What interventions are being tested in trial NCT03914612?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Computed Tomography (PROCEDURE), Paclitaxel (DRUG), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT03914612?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03914612 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03914612's enrollment target sits among peer trials
813 2nd of 19 the highest of 19 other Recurrent Endometrial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Endometrial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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